Single channel cartridge device for coagulation assays in fluid samples

Abstract

The present invention relates to analytical testing devices comprising a single channel with micro-environment sensors and methods for assaying coagulation in a fluid sample applied to the micro-environment sensors, and in particular, to performing coagulation assays using a single channel with micro-environment sensors in a point of care test cartridge. For example, the present invention may be directed to a sample analysis cartridge including an inlet chamber configured to receive a biological sample and a conduit fluidically connected to the inlet chamber. The conduit includes a sensor chip including a first micro-environment sensor and a second microenvironment sensor, and a fluid lock valve. The sample analysis cartridge further includes a pump configured to push the biological sample over the first micro-environment sensor and the second microenvironment sensor to the fluidic lock valve such that the biological sample is positioned over the first micro-environment sensor and the second micro-environment sensor.

We claim: 
     
       1. A sample analysis cartridge comprising:
 an inlet chamber configured to receive a biological sample; 
 a conduit fluidically connected to the inlet chamber and configured to receive the biological sample from the inlet chamber, the conduit comprising:
 a sensor chip including a first micro-environment sensor and a second micro-environment sensor, 
 a first reagent comprising a first enzyme substrate, the first reagent formed on and/or adjacent to the first micro-environment sensor, 
 a second reagent comprising a second enzyme substrate, the second reagent formed on and/or adjacent to the second micro-environment sensor, and 
 a fluidic lock valve; and 
 
 a pump configured to push the biological sample over the first micro-environment sensor and the second micro-environment sensor to the fluidic lock valve such that the biological sample is positioned over the first micro-environment sensor and the second micro-environment sensor, 
 wherein each of the first micro-environment sensor and the second micro-environment sensor includes at least one transducer coated with a polymer layer, the first reagent is integrated within, coated over and/or positioned adjacent to the polymer layer of the first micro-environment sensor, and the second reagent is integrated within, coated over and/or positioned adjacent to the polymer layer of the second micro-environment sensor. 
 
     
     
       2. The sample analysis cartridge of  claim 1 , wherein the first micro-environment sensor is a sensor for detecting prothrombin time (PT), and the second micro-environment sensor is a sensor for detecting activated partial thromboplastin time (aPTT). 
     
     
       3. The sample analysis cartridge of  claim 2 , wherein
 the first reagent comprises a first thrombin-cleavable peptide with a detectable moiety; 
 the second reagent comprises a second thrombin-cleavable peptide with a detectable moiety; and 
 the first thrombin-cleavable peptide is different from the second thrombin-cleavable peptide. 
 
     
     
       4. The sample analysis cartridge of  claim 2 , wherein the first reagent includes one or more components for triggering an extrinsic pathway of coagulation in the biological sample, and the second reagent includes one or more components for triggering an intrinsic pathway of coagulation in the same biological sample. 
     
     
       5. The sample analysis cartridge of  claim 1 , wherein the fluidic lock valve is a membrane sponge valve, a microchannel capillary, a micro-array valve, or a capillary burst valve. 
     
     
       6. The sample analysis cartridge of  claim 1 , further comprising an overflow conduit fluidically connected to the conduit at a junction, the overflow conduit comprises a flow restrictor region configured to divert flow of the biological sample to the first micro-environment sensor and the second micro-environment sensor. 
     
     
       7. The sample analysis cartridge of  claim 1 , wherein each of the first micro-environment sensor and the second micro-environment sensor is an amperometric sensor or an optical sensor.